What side effects are associated with this type of intervention?

Deep Brain Stimulation (DBS) for Parkinson's Disease can lead to side effects such as infection at the surgical site, bleeding in the brain, and hardware complications like lead migration or breakage. Patients may also experience mood changes, cognitive disturbances, and speech problems. Common pharmacologic treatments, such as levodopa, can cause motor fluctuations, dyskinesias, nausea, and orthostatic hypotension. Dopamine agonists may lead to impulse control disorders, hallucinations, and sleep disturbances.

What prior FDA approvals exist?

Deep Brain Stimulation (DBS) has been FDA-approved for the treatment of Parkinson's Disease, specifically targeting motor symptoms that are not adequately controlled by medication. DBS involves the implantation of electrodes that send electrical impulses to specific brain regions, such as the subthalamic nucleus or globus pallidus. Other FDA-approved treatments for Parkinson's Disease include pharmacologic agents like levodopa, dopamine agonists, MAO-B inhibitors, and amantadine, which help manage motor symptoms by modulating dopaminergic activity in the brain.

What other types of research exist?

Promising, novel alternatives to the Medtronic Percept PC DBS system for Parkinson's Disease patients in 2024 include: 1) Adaptive Deep Brain Stimulation (aDBS), which adjusts stimulation in real-time based on neural feedback; 2) Focused Ultrasound (FUS), a non-invasive technique that uses targeted ultrasound waves to modulate brain activity; and 3) Gene Therapy approaches, such as those delivering GDNF (glial cell line-derived neurotrophic factor) to support dopaminergic neurons. These alternatives are currently under investigation and show potential for improving motor symptoms in PD patients.

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Exercise for Parkinson's Disease

N/A

Recruiting

Research Sponsored by The Cleveland Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up an average of 3 total days

Awards & highlights

No Placebo-Only Group

Summary

This trial involves people with Parkinson's Disease doing two types of stationary bike exercises. One type is where they pedal at their own pace, and the other is where they are helped to pedal faster. The goal is to see if higher intensity exercise can improve their symptoms more effectively.

Who is the study for?

This trial is for adults with Parkinson's Disease (PD) who have had a Medtronic Percept PC DBS system in place for at least six months and stable settings for three. Participants must be able to stop PD medications and DBS, pass an exercise safety screening or get doctor clearance, and safely use a recumbent cycle.

What is being tested?

The study tests the effects of one session each of forced (FE) and voluntary exercise (VE) on cognitive function in PD patients without their usual medication or DBS stimulation. The exercises are done during a single 150-minute session.

What are the potential side effects?

Potential side effects from participating may include typical risks associated with physical exercise such as muscle strain, fatigue, or cardiovascular stress especially since participants will not take their regular PD medication during sessions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ an average of 3 total days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~an average of 3 total days

This trial's timeline: 3 weeks for screening, Varies for treatment, and an average of 3 total days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Force-tracking with n-back

Information Processing

Local Field Potentials during Cognitive Testing

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Experimental ArmExperimental Treatment1 Intervention

Two modes of high intensity exercise.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Parkinson's Disease (PD) primarily aim to manage motor symptoms by addressing the dopamine deficiency in the brain. Levodopa, the most effective treatment, is converted to dopamine in the brain, replenishing the diminished neurotransmitter. Dopamine agonists mimic dopamine's effects by stimulating dopamine receptors, while MAO-B inhibitors prevent the breakdown of dopamine, prolonging its action. Deep Brain Stimulation (DBS), such as the Medtronic Percept PC DBS system, involves implanting electrodes in specific brain regions to modulate neural activity. This can significantly alleviate motor symptoms by restoring more normal patterns of brain activity. These treatments are crucial for improving the quality of life in PD patients by reducing symptoms like tremors, rigidity, and bradykinesia.